Obstetric Outcome In Parturiant Women Without Episiotomy Versus With Episiotomy- A Randomised Controlled Trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Maternal outcomes:
研究概览
简要总结
Parturiant women admitted in the Labour room at NKP Salve Institute of Heath Sciences and Research Center and Lata Mangeshkar Hospital are being recruited in the trial depending on inclusion and exclusion criteria. The parturient women are divided in two groups - with Episiotomy and without Episiotomy and then effects on both mother and newborn are well evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Low risk primary and multigravida women between 37 to 42 weeks of gestation, singleton pregnancy, cephalic presentation, occipito-anterior position with adequate pelvis presenting in active stage of labour
- •Baby weightless than 3 Kg
- •Those willing to provide informed consent.
排除标准
- •Women requiring cesarean section during second stage of labour.
- •Maternal and fetal distress.
结局指标
主要结局
Maternal outcomes:
时间窗: Outcomes will be assessed at the time of second stage of delivery and daily for 3 days post delivery
1. Duration of second stage of labour
时间窗: Outcomes will be assessed at the time of second stage of delivery and daily for 3 days post delivery
2. Frequency and degree of perineal tear
时间窗: Outcomes will be assessed at the time of second stage of delivery and daily for 3 days post delivery
3. Postpartum pain
时间窗: Outcomes will be assessed at the time of second stage of delivery and daily for 3 days post delivery
4. Postpartum requirement of analgesia
时间窗: Outcomes will be assessed at the time of second stage of delivery and daily for 3 days post delivery
Neonatal outcomes:
时间窗: Outcomes will be assessed at the time of second stage of delivery and daily for 3 days post delivery
1. APGAR score at 1 min
时间窗: Outcomes will be assessed at the time of second stage of delivery and daily for 3 days post delivery
2. APGAR score at 5 mins
时间窗: Outcomes will be assessed at the time of second stage of delivery and daily for 3 days post delivery
3. Requirement of neonatal resuscitation
时间窗: Outcomes will be assessed at the time of second stage of delivery and daily for 3 days post delivery
4. NICU admission
时间窗: Outcomes will be assessed at the time of second stage of delivery and daily for 3 days post delivery
次要结局
- Not Applicable(Not Applicable)
研究者
Dr Srishti Kalra
NKP Salve Insititute Of Medical Sciences And Research Center And Lata Mangeshkar Hospital